Reported Dec 24, 2025 · Ongoing
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE Healthcare GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare GmbH · Oskar-Schlemmer-Str. 11 · Munich · N/A
Is this the product you have?
GE HealthCare ViewPoint 6Catalog Number H47601AARadiological image processing system
- Lot codes and dates
ViewPoint 6 version 6.15.3UDI (01)00195278753472(10)ViewPoint6.15.3.0
- System ID numbers
810 of 810 codes
F0HD Y23WTR41 MQHHMMZR D4YSYJJM BH2002GQ KX8NY13Z CK8A215K QT2PR2RQ 6S9K3SD3 XRBX64TY MCQ5SU3C 35BJFURE QR5U493M 8J65E206 FXM20QN8 K9Z52PM0 2G22Y3EK ZG4HXM7F JE94T-XQH5 RGGWJXAK BGRNX563 55KCQ759 NQ3TYUC5 E1B7M4DN P5QTHJU6 59Y2PXDU YRPAXDRU PP57GA26 M2DT7QZY K6XBFH9H X5S1HH3Y Y4W3R4JZ 668A8E00 EY8ABSB4 FJDKT-BSB4 FJDKCR6U 0AQ120XB 0UASSKSK 3JNJKUT3 2W8P7H6Q RE0Z5KDZ 640J1M4R 8H6RT-KN5N NE40KN5N NE40576N X8R0B8R9 HHAPNFG0 C3GZR546 M5JWT-R546 M5JW959J 7955CCZ5 BXGJAXDF 5QS973C8 M5NZGZZ6 R27YPT24 XDAMEMUP X20W1J2C FXHST-1J2C FXHS3DUC WYDKTG21 RSW3
- System ID numbers
413 of 413 codes
0YB0 MCSKH11S KECJBDQ0 8B7AACP6 E9U62HD6 1CNZE8E2 KA1N0A64 BXF0HJSP 2J83D93B J00KMSXR PRQDXTZN HZZZT-XTZN HZZZGARP HXEJJJ90 AHW6FTXK 34Y06MB1 4CB4WSUU 3B1BX89G SQDEKJC2 X4TYQY6G YT315BZ2 5WJEJ2AF 8037SKDB B40URRED Z0WMZR7Z NS9KB9KW WRBUXWP6 BCXBTYN4 CNSR3X5B 37QXT-3X5B 37QXZ03G EMFA66U5 1C2A9XZC ZQGDE3CT 79RAZ3EW WND9T-F7RD DEWFZT4Y 8B0RZX0E SSG4T48W 45XMT-T48W 45XMJAPJ UYWPNDMG F4KTRC62 AFP87GX0 XP0UU565 TH83G762 X178HY37 EPMY16FQ YP4YB4NP RBY6B26E J9316CSS DWSXBS3F 043Z94M2 14C9U92B RKHM3MJC 527M7Q8J KG6Z962C P7RPT1EX R8RGHMZK 81W28CY4 4FW8
- Amount recalled
- 1221 units
Why it was recalled
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
This product could cause temporary or reversible health problems — stop using it.
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